MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem High Readings (2459)

Patient Problem Hyperglycemia (1905)

Event Date 04/04/2021

Event Type  Injury  

Event Description

Incorrectly reporting blood; abbott freestyle libre reported 200 mg/dl.Bgm read 127 mg/dl.Kept libre on for 8 more hours.Glucose levels still 50 to 80 unit too high.Replaced sensor.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 11633684
• MDR Text Key: 244654310
• Report Number: MW5100636
• Device Sequence Number: 1
• Product Code: MDS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 70 YR
• Patient Weight: 106